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Renal Function, Efficacy, and Safety of Sirolimus and Mycophenolate Mofetil After Short-Term Calcineurin Inhibitor-Based Quadruple Therapy in De Novo Renal Transplant Patients: One-Year Analysis of a Randomized Multicenter Trial

2010; Wolters Kluwer; Volume: 90; Issue: 2 Linguagem: Inglês

10.1097/tp.0b013e3181e11798

1534-6080

Markus Guba, Johann Pratschke, Christian Hugo, Bernhard K. Krämer, Constanze Nohr-Westphal, Jens Brockmann, Joachim Andrassy, Petra Reinke, Katharina Pressmar, Oliver W. Hakenberg, Michael Fischereder, Andreas Pascher, Wolf‐Dieter Illner, Bernhard Banas, Karl‐Walter Jauch,

Neurological Complications and Syndromes

Background. De novo sirolimus in calcineurin inhibitor-free regimens, although potentially useful to improve early renal function, are complicated by various drug-related side effects. Methods. We report a prospective open-label, multicenter, randomized trial to evaluate early conversion from a CsA-based to a sirolimus (SRL)-based regimen 10 to 24 days after renal transplantation. Of the 196 patients, 141 patients with a low-to-moderate immunological risk were eligible to be converted to SRL or to continue CsA. All patients received antithymocyte globulin-F single-bolus induction, mycophenolate mofetil, and steroids. Results. The primary endpoint, renal function determined by S-creatinine and estimated glomerular filtration rate calculated by Nankivell formula at 12 months was significantly better in the SRL group (1.51±0.59 vs. 1.87±0.98 mg/dL or 64.5±25.2 vs. 53.4±18.0 mL/min/1.73 m2). Patient survival, graft survival, and incidence of biopsy-proven acute rejection after conversion were not statistically different. Drug discontinuations were significantly higher in the SRL group (36.2% vs. 19.7%). Significantly, more patients in the SRL group reported acne, aphtous, and temporary hyperlipidemia, whereas cytomegalovirus viremia was significantly decreased (7.3% vs. 28.2%). Conclusions. Early conversion to a calcineurin inhibitor-free regimen with SRL in combination with mycophenolate mofetil may be a useful strategy to improve renal function. The identification of appropriate candidates and safe management of SRL-related adverse events will be a key to avoid the high rate of dropouts, which currently limit the broad applicability of this protocol.